Irritable Bowel Syndrome
Conditions
Brief summary
Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori infection. It has been proposed that Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed investigation is to determine whether the administration of Bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.
Interventions
DRUGBacillus clausii
Oral suspension administered BID
DRUGTrimebutine
One tablet of 200 mg of trimebutine administered BID
Sponsors
Hospital Britanico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria
Exclusion criteria
* Allergy to Bacillus clausii spores * Prior treatment with antibiotics or probiotics (4 weeks) * Not willing to fulfill symptom diary * Pregnancy or breastfeeding * Clinical suspicion of organic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic response | After two weeks of treatment | Decrease of at least 50% of symptom severity score - The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500. Based on previously published studies, clinical response will be defined as a decrease in at least 50% of the initial score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic relapse | Four weeks after treatment completion | An increase of at least 30% in the symptomatic score based on daily follow up. The score that will be used is the The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500. |
Countries
Argentina
Outcome results
None listed